(85 days)
MTA-Fillapex is a root canal sealer intended for the permanent scaling of root canals and may be used in combination with root canal obturation materials.
MTA Fillapex is a mineral trioxide aggregate (MTA) and resin toot canal sealer used during endodontic treatment to permanently fill the canal system following debridement and disinfection. It consists of two component pastes that are combined in a dual barrel syringe for ease of dispensing and consistent dosage. Being hydrophilic in nature, MTA-FILLAPEX is desirable as a root filling material because an isolated dry field is not necessary for use. Moisture does not negatively affect the sealing ability and is required for proper setting. It is used in combination with gutta-percha or silver points during root canal obturation.
The provided text describes the 510(k) submission for MTA Fillapex, a root canal sealer. It details performance criteria and tests conducted to demonstrate substantial equivalence to predicate devices, especially a modified version of K113568 with the addition of titanium dioxide to the base paste. However, this document does not describe a study, or acceptance criteria, for a device that uses AI. Instead, it's for a dental material (root canal sealer). Therefore, many of the requested fields related to AI/algorithm performance are not applicable.
Here's an analysis based on the provided text, focusing on the material it does describe:
1. Table of acceptance criteria and the reported device performance
| Test Performed | Acceptance Criteria | Reported Device Performance (MTA Fillapex) | Source (pages) |
|---|---|---|---|
| Working time | 23 minutes | 23 minutes | 2, 3 |
| Setting time | 130 minutes | Minimum 130 minutes (Table 1), 130 minutes (Table 2) | 1, 3 |
| Flow | Minimum of 20 mm | 33.38 mm (Table 1) | 1, 3 |
| Radiopacity | Minimum of 3 mm | Greater than 3mm of the aluminium scale | 3 |
| Solubility | Maximum 3% | 2.47% (Table 1) | 1, 3 |
| Internal Tests | |||
| Flow/Viscosity (Base Paste) | 20-22 mm | Not explicitly stated for specific paste, but "Flow: 33.38 mm" is reported for the mixed product | 1, 3 |
| Flow/Viscosity (Catalyst Paste) | 27-29 mm | Not explicitly stated for specific paste, but "Flow: 33.38 mm" is reported for the mixed product | 1, 3 |
| Flow/Viscosity (Mixed pastes after 30 min) | 21-23 mm | Not explicitly stated for specific paste, but "Flow: 33.38 mm" is reported for the mixed product | 1, 3 |
| Radiopacity | Greater than 3mm of the aluminium scale | Greater than 3mm of the aluminium scale | 3 |
| Setting time | 130 minutes | 130 minutes | 3 |
| Free lime content | 3-5% | Not explicitly stated in performance (only acceptance criteria) | 3 |
| Biocompatibility | Biocompatible | Biocompatible (based on prior K113568 testing) | 1, 2 |
| Shelf Life | 2 years | 2 years | 1, 2 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes used for each test beyond numerical results (e.g., "33.38 mm" for flow). The data provenance is also not specified in terms of country of origin or whether it was retrospective or prospective. The tests were performed as "Design Verification Tests" in response to a "Failure Modes and Effects Analysis (FMEA)" related to a modification (addition of titanium dioxide).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is for a dental material, not an AI/software device requiring expert ground truth for classification or diagnosis. Performance metrics are based on physical and chemical properties and industry standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is for a dental material; there is no adjudication process involving multiple human readers for performance metrics like flow or setting time.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is for a dental material, not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is for a dental material, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the physical and chemical properties (flow, setting time, solubility, radiopacity, etc.), the "ground truth" is established by adherence to industry standards (specifically ISO 6876:2012) and established laboratory testing protocols. For biocompatibility, reliance is placed on previous testing for the predicate device (K113568) and the chemical composition.
8. The sample size for the training set
Not applicable. This is for a dental material, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is for a dental material, not an AI model.
§ 872.3820 Root canal filling resin.
(a)
Identification. A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.(b)
Classification. (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.